Process Development Consultant
Type: Contract
Manufacturing
Industry: Life Sciences
Workplace Type: Remote
A growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale‑Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full‑scale launch. Ideal candidates bring big‑company, multi‑step catheter manufacturing expertise and a proven track record in outsourced medical device scale‑up.
Outsourced Manufacturer Selection & Onboarding
Conduct site visits, due diligence, and comparative assessments for capacity, quality systems, and regulatory readiness
Lead knowledge transfer sessions, ensuring clear documentation of current catheter assembly processes
Develop and manage pilot manufacturing proto...